Innova™ Vascular H74939293064030Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729873990), received between Jun 7, 2017 and Jul 25, 2024 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (P140028); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6MM X 40MM X 130CM INNOVA SELF-EXPANDING STENT SYSTEM WAS SELECTED FOR USE. DURING PREPARATION WITH A SYRINGE ON THE BACK TABLE OUTSIDE THE PATIENT, THE STENT DEPLOYED EARLY. THE SAFETY LOCK WAS NOT REMOVED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833665 ↗
• MalfunctionFeb 14, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED DURING DEVICE PREPARATION. AN INNOVA 6 X 40 X 130 WAS SELECTED FOR USE TO TREAT THE PATIENTS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) STENOSIS. DURING DEVICE PREPARATION, THE STENT PARTIALLY DEPLOYED PRIOR TO ENTERING THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER INNOVA 6 X 40 X 130 IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375825 ↗
• MalfunctionOct 2, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 6 X 40 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR A PERIPHERAL SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY AND STENTING PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE. DURING PREPARATION, HOWEVER, THE STENT WAS DEPLOYED UPON REMOVAL FROM THE PACKAGING ON THE BACK TABLE. IT WAS NOTED THAT THE THUMBWHEEL WAS NOT CLICKED. ANOTHER INNOVA VASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526164 ↗
• MalfunctionApr 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE TIP FRACTURED. A 6X40X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE TO TREAT ARTERIAL STENOSIS IN THE LEFT LEG. UPON REMOVAL FROM THE PACKAGING A FRACTURE TO THE DISTAL TIP WAS OBSERVED. THE CATHETER SHEATH WAS NOTED TO BE MOVING FREELY. A NEW STENT, SAME MODEL, WAS OPENED AND SUCCESSFULLY DELIVERED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651985 ↗
• MalfunctionMar 12, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED. A 6MM X 40MM X 130CM INNOVA STENT WAS SELECTED FOR USE IN A PROCEDURE, WITHIN THE MID PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, AS THE STENT WAS BEING LOADED ONTO THE GUIDEWIRE, THE HEALTH CARE PROVIDER (HCP) NOTICED THE STENT WAS PARTIALLY DEPLOYED ABOUT 5MM. THE THUMB WHEEL WAS NOT USED OR ACTIVATED. THE STENT REPORTEDLY FELT STUCK ON THE GUIDEWIRE AND THE HCP HAD A DIFFICULT TIME UNLOADING THE STENT OFF THE WIRE. THE DEVICE WAS SAFELY REMOVED FROM THE GUIDEWIRE AND WAS DISCARDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE STENT DID NOT ENTER THE PATIENT AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475114 ↗
• MalfunctionMay 4, 2020Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE SUBCLAVIAN VEIN (SCV). PRE-DILATION WAS PERFORMED RESULTING IN A LESS THAN 50% STENOSED LESION. A NON-BSC GUIDEWIRE AND 6 FR ACCESS SHEATH WERE USED AND THE DEVICE WAS DELIVERED VIA ANTEGRADE APPROACH. IT WAS REPORTED THAT IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE LESION, THE WIRE DID NOT HAVE SMOOTH MOVEMENT. DESPITE LUBRICATING THE DEVICE THE STENT DEPLOYED APPROXIMATELY TWO STRUTS DESPITE THE SAFETY LOCK REMAINING ON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020907 ↗
• MalfunctionApr 15, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X40X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN THE LEFT LEG. DURING THE PROCEDURE, THEY WERE ADVANCING THE STENT ON THE WIRE OVER THE ILIAC IN NORMAL, NON-TORTUOUS ANATOMY WHEN THE STENT BEGAN TO DEPLOY. THE LOCK WAS STILL IN PLACE. THE DEVICE WAS ABLE TO BE RETRIEVED SUCCESSFULLY WITHOUT FULL DEPLOYMENT OF THE STENT. A NEW STENT WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS REPORTED AS DOING GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962436 ↗
• MalfunctionSep 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS A FOCAL LESION MEASURING 5.4MM WITH A LENGTH OF 34MM. A 6X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED INTO THE ARTERY, THE STENT BEGAN TO UNSHEATH PREMATURELY. THE SAFETY MECHANISM WAS STILL IN PLACE. THE PHYSICIAN MANUALLY REMOVED THE DEVICE FROM THE ARTERY; IT WAS NOT DEPLOYED IN THE ARTERY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125016 ↗
• MalfunctionSep 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT DEPLOYED IN THE SHEATH. A 6X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS INSERTING THE INNOVA DEVICE, THE STENT CAME OFF INSIDE THE DELIVERY SYSTEM SHEATH. THE STENT WAS STUCK IN THE SHEATH AND THE DEVICES WERE REMOVED TOGETHER WHEN THE SHEATH WAS EXCHANGED. THEY CONTINUED THE CASE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124291 ↗
• MalfunctionMar 25, 2019Material Integrity Problem; Activation Problem; Material Integrity Problem; Activation Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 6X40X130 INNOVA VASCULAR STENT WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE SEVERELY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION WAS ACCESSED BY IPSILATERAL APPROACH. AFTER THE UNSPECIFIED GUIDEWIRE WAS PASSED THROUGH, AND THE STENT DELIVERY SYSTEM WAS DELIVERED TO THE TARGET LESION, THE PHYSICIAN TRIED TO PERFORM STENTING WITH THIS DEVICE, BUT THE THUMBWHEEL WOULD NOT MOVE/ACTIVATE WHILE ATTEMPTING TO DEPLOY THE STENT, SO THE DEVICE WAS REMOVED. WHEN CHECKING THE DEVICE AFTER REMOVAL, THE DISTAL TIP OF THE STENT STRUTS WERE FOUND TO BE FLARED AND LIFTED UP. THEREFORE THE DEVICE WAS REPLACED WITH AN ELUVIA STENT TO COMPLETE THE STENTING. THE SAME UNSPECIFIED GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449848 ↗
• MalfunctionJan 3, 2019Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6X40X130 INNOVA DEVICE WAS SELECTED FOR A STENTING PROCEDURE IN THE RIGHT INTERNAL ILIAC. DURING THE PROCEDURE, THE INNOVA FAILED TO ADVANCE THROUGH THE SHEATH. THE DEVICE WAS REMOVED AND INSPECTED. IT WAS NOTED THAT THE LEADING EDGE OF THE STENT WAS EXPOSED. THE DEVICE WAS REMOVED COMPLETELY AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214639 ↗
• MalfunctionNov 29, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS DISLODGED. A 6 X 40 X 130MM INNOVA STENT WAS SELECTED FOR USE. DURING PREPARATION, THE STENT WAS REMOVED FROM THE PACKAGING AND PRE-DILATED. THE STENT THEN DEPLOYED AND CAME OFF OF THE DELIVERY SYSTEM BEFORE IT WAS ABLE TO BE USED INSIDE THE PATIENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT SYSTEM WITH THE THUMBWHEEL PROTECTOR. VISUAL EXAMINATION REVEALED A KINK AT THE NOSECONE. KINKS AT THE NOSECONE ARE USUALLY CAUSED BY HANDLING AND/OR PACKAGING THE PRODUCT TO BE RETURNED. THE YELLOW THUMBWHEEL PROTECTOR IS STILL ATTACHED BUT IS ON BACKWARDS. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY DAMAGES. THE STENT DID NOT RETURN WITH THE DEVICE. THERE IS BLOOD PRESENT IN THE INNER LINER. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Patient Involvement

  MAUDE report 8116986 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS ACUTE STENT THROMBOSIS UPON IMPLANTATION. PRIOR TO THE PROCEDURE THE PATIENT WAS ADMINISTERED 4000 UNITS OF HEPARIN. THE LESION WAS LOCATED IN THE PROXIMAL PART OF THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION, A 6 X 40 X 130 INNOVA STENT WAS DEPLOYED WITHOUT ISSUES. THE PATIENT DEVELOPED CLOT IMMEDIATELY. THE PHYSICIAN WAS NOT AWARE THAT THE PATIENT WAS HEPARIN RESISTANT. IMAGING SHOWED THAT THE STENT WAS COMPLETELY CLOGGED AND EVEN BEYOND THE STENT THERE WAS CLOT. AN ADDITIONAL 12000 UNTIS OF HEPARIN WAS ADMINISTERED AND THAT DID NOT RESOLVE THE CLOTS. TPA WAS DIRECTLY ADMINISTERED INTO THE SITE WHICH CLEARED SOME OF THE CLOTS. A BSC ANGIOJET SOLENT CATHETER WAS USED TO CLEAR THE REMAINING CLOTS. THE CLOTS WERE CLEARED AND THE PATIENT IS FINE.

  Patient problems: Thrombosis

  MAUDE report 7975384 ↗
• MalfunctionJan 9, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT DEPLOYED PREMATURELY. A 6X40X130 INNOVA¿ STENT WAS SELECTED FOR AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE PHYSICIAN WAS INSERTING THE STENT OVER THE WIRE AND THE STENT DEPLOYED PREMATURELY BEFORE PUTTING THE CATHETER INTO THE SHEATH. THE SAFETY LOCK WAS STILL ON. THE STENT AND CATHETER WERE SAFELY REMOVED BACK OFF THE WIRE WITH NO ADDITIONAL MANEUVERS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177288 ↗
• InjuryNov 28, 2017Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. A 6X40X130 INNOVA¿ STENT WAS SELECTED FOR A LEFT LEG STENTING PROCEDURE IN THE LEFT COMMON FEMORAL ARTERY. THE PHYSICIAN DEPLOYED THE STENT AND IT COVERED THE PROFUNDA. THE PHYSICIAN ATTEMPTED TO DRAG THE STENT BELOW THE PROFUNDA WITH A BALLOON AND THE STENT APPEARED TO FRACTURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN STATED THE STENT WAS FINE AND HE WAS OKAY WITH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063340 ↗
• MalfunctionJun 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. DURING PREPARATION THE 6X40X130MM INNOVA¿ STENT INADVERTENTLY DEPLOYED OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140028. One submission often covers many models, so check the product and lot details in each record.

• Z-0685-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated t
• Z-0686-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated